Libby's H*O*P*E*

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FDA Issues a Warning Letter to LabCorp Regarding The Illegal Marketing of The OvaSure™ Test

Posted by Paul Cacciatore on October 8, 2008

On September 29, 2008, the U.S. Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health, issued a warning letter (FDA Warning Letter) to the Chief Executive Officer of the Laboratory Corporation of America (LabCorp) regarding the illegal marketing of the OvaSure™ ovarian cancer early detection diagnostic test. …Steven Gutman, M.D., M.B.A., the OIVD Director, informed David P. King, President and Chief Executive Officer of LabCorp, that his company was in serious violation of the Food, Drug, and Cosmetic Act (FDCA) involving the illegal marketing of the OvaSureTM test and asked that the violations be promptly corrected to avoid initiation of regulatory action by the FDA.

On September 29, 2008, the U.S. Food and Drug Administration (FDA), Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health, issued a warning letter (the FDA Warning Letter) to the Chief Executive Officer of the Laboratory Corporation of America (LabCorp) regarding the illegal marketing of the OvaSure™ ovarian cancer early detection diagnostic test.

In the September 29th FDA Warning Letter, Steven Gutman, M.D., M.B.A., the OIVD Director, informed David P. King, President and Chief Executive Officer of LabCorp, that his company was in serious violation of the Food, Drug, and Cosmetic Act (FDCA) involving the illegal marketing of the OvaSureTM test and asked that the violations be promptly corrected to avoid initiation of regulatory action by the FDA. The FDA Warning Letter was issued to LapCorp after review of information obtained from LabCorp’s website including a press release and a technical bulletin, as well as information provided by LabCorp in a face-to-face meeting with the FDA on September 5, 2008.

The FDA Warning Letter to LapCorp states that the OvaSure™ test is a “device” under the FDCA because it is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease. Once classified as a “device” under the FDCA (assuming non-applicability of select exemption criteria), LapCorp is required by law to obtain marketing approval or clearance for the OvaSure™ test from the FDA prior to its sale to the public. This FDA finding, in theory, helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

Based upon OIVD’s findings, the FDA concluded that LapCorp did not obtain FDA marketing approval or clearance for the OvaSure™ test and is in violation of Federal law. Specifically, the FDA describes LapCorp’s violations of, and the required corrective action under, the FDCA as follows:

“… The device [i.e., OvaSure™] is adulterated under section 501(f)(1)(B) of the [Food, Drug, and Cosmetic] Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) [of] the Act, 21 U.S.C. 352(o), because you did not notify the agency [i.e., the FDA] of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR §807.81(b). …

… You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”

The FDA Warning Letter provides LapCorp with 15 working days to correct its violations under the FDCA as noted above, and to explain how such violations will be prevented in the future. The FDA requests LapCorp to notify the agency if such corrective action cannot be taken within the specified 15 working day time frame.

Libby’s H*O*P*E*™ covered the initial marketing release of LabCorp’s OvaSure™ test and the FDA’s initial inquiry into the clinical validation support underlying the marketing of that test on June 23, 2008 and August 23, 2008, respectively.

Source: FDA Issued a Warning Letter to the CEO of LabCorp Regarding The Illegal Marketing of The OvaSureTM Test, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. September 29, 2008.

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